Fudakang Industrial Co Ltd
Dongguan Guangdong, CN
FUDAKANG INDUSTRIAL CO LTD appears in FDA device records in Dongguan Guangdong, CN. FDA records list 4 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Fudakang Industrial Co Ltd between 2012 and 2018. The busiest year on record is 2012, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172121 | Digital Thermometer | FLL | Substantially Equivalent | |
| K160308 | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) | FLL | Substantially Equivalent | |
| K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K111703 | INFRARED EAR THEROMETER | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008167616 | 3008167616 | FUDAKANG INDUSTRIAL CO LTD | 501, Building 2, No. 11 Changheng Road,, Dongguan Guangdong 523560 CN | 2026 | |
| 3008581794 | 3008581794 | Fudakang Industrial Inc. | 3514 Raina Ridge Court, Las Vegas, NV 89121 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain